Managing Your FDA Inspection_ Before During and After (ntz)
- hace 6 años
Managing Your FDA Inspection: Before, During and After (ntz)
At
Courtyard by Marriott Seattle Sea-Tac Area
For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV
DESCRIPTION
===========
FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one.
During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills.
As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions.
If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster.
FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face.
he course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents.
What the investigator does and what FDA does are not mysteries, they just seem like it.
Why you should attend:
"Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol.
For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV
Areas Covered in the Session
============================
FDA legal authority
Types of inspections
FDA investigator training
FDA's written procedures, policy and operations guide
Industry inspection protocol
What to do and not do during an inspection
Form FDA 483 response
Warning Letter response
Enforcement
Who Will Benefit:
=================
Regulatory Affairs
Quality Assurance
Manufacturing
Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRH
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
----------------------------------
For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
Twitter: https://twitter.com/nyeventslist
Facebook: https://www.facebook.com/NewYorkEventsList
New York Events List: http://nyeventslist.com/
At
Courtyard by Marriott Seattle Sea-Tac Area
For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV
DESCRIPTION
===========
FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one.
During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills.
As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions.
If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster.
FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face.
he course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents.
What the investigator does and what FDA does are not mysteries, they just seem like it.
Why you should attend:
"Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol.
For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV
Areas Covered in the Session
============================
FDA legal authority
Types of inspections
FDA investigator training
FDA's written procedures, policy and operations guide
Industry inspection protocol
What to do and not do during an inspection
Form FDA 483 response
Warning Letter response
Enforcement
Who Will Benefit:
=================
Regulatory Affairs
Quality Assurance
Manufacturing
Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRH
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
----------------------------------
For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
Twitter: https://twitter.com/nyeventslist
Facebook: https://www.facebook.com/NewYorkEventsList
New York Events List: http://nyeventslist.com/